Benadryl Allergy Sinus Headache Side Effects

Generic Name: acetaminophen / pseudoephedrine

Note: This page contains information about the side effects of acetaminophen / pseudoephedrine. Some of the dosage forms included on this document may not apply to the brand name Benadryl Allergy Sinus Headache.

Not all side effects for Benadryl Allergy Sinus Headache may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to acetaminophen / pseudoephedrine: capsules, tablets

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur while taking acetaminophen / pseudoephedrine:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mood or mental changes; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; tremor; vision changes; yellowing of skin or eyes.

For Healthcare Professionals

Applies to acetaminophen / pseudoephedrine: oral capsule, oral liquid, oral tablet, oral tablet chewable

Cardiovascular

Cardiovascular adverse effects of pseudoephedrine have included significant rises in heart rate. Hypertension and arrhythmias have been problematic in susceptible patients.[Ref]

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.[Ref]

Nervous system

Nervous system side effects of pseudoephedrine have included nervous system stimulation, resulting in tremor, anxiety, and nervousness. Insomnia has been reported in up to 30% of pseudoephedrine-treated patients. Headache has also occurred in patients receiving pseudoephedrine.[Ref]

Hepatic

Hepatic side effects of acetaminophen have been rare, except in alcoholics and after overdose. In these settings, severe and sometimes fatal (3% to 4%) dose-dependent hepatitis has been reported. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity[Ref]

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person, although hepatotoxicity has been reported with smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

A 19-year-old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.[Ref]

Gastrointestinal

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism for this side effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of oddi.[Ref]

Gastrointestinal side effects of acetaminophen are rare, except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely with acetaminophen use.

Gastrointestinal side effects of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat has occurred in up to 15% of patients.[Ref]

Renal

Renal side effects of acetaminophen have been rare and included acute tubular necrosis and interstitial nephritis. Adverse renal effects were most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.[Ref]

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases.[Ref]

Hematologic

Hematologic side effects have included rare cases of thrombocytopenia associated with acetaminophen. Acute thrombocytopenia has also been reported as having been caused by sensitivity to acetaminophen glucuronide, the major metabolite of acetaminophen. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.[Ref]

Hypersensitivity

Hypersensitivity reactions to pseudoephedrine have included fixed drug eruptions.[Ref]

Dermatologic

Dermatologic side effects have included rare reports of general erythematous skin rashes associated with acetaminophen. A rare case of bullous erythema associated with acetaminophen has been reported. Acetaminophen has been associated with a risk of rare but potentially fatal serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).[Ref]

Metabolic

Metabolic side effects including metabolic acidosis have been reported following a massive overdose of acetaminophen.

In the case of metabolic acidosis, causality is uncertain as more than one drug was ingested. The case of metabolic acidosis followed the ingestion of 75 grams of acetaminophen, 1.95 grams of aspirin, and a small amount of a liquid household cleaner. The patient also had a history of seizures which the authors reported may have contributed to an increased lactate level indicative of metabolic acidosis.

References

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4. Stroh JE, Jr Ayars GH, Bernstein IL, Kemp JP, Podleski WK, Prenner BM, Schoenwetter WF, Salzmann JK "A comparative tolerance study of terfenadine-pseudoephedrine combination tablets and pseudoephedrine tablets in patients with allergic or vasomotor rhinitis." J Int Med Res 16 (1988): 420-7

5. Wiener I, Tilkian AG, Palazzolo M "Coronary artery spasm and myocardial infarction in a patient with normal coronary arteries: temporal relationship to pseudoephedrine ingestion." Cathet Cardiovasc Diagn 20 (1990): 51-3

6. Gordon RD, Ballantine DM, Bachmann AW "Effects of repeated doses of pseudoephedrine on blood pressure and plasma catecholamines in normal subjects and in patients with phaeochromocytoma." Clin Exp Pharmacol Physiol 19 (1992): 287-90

7. Dickerson J, Perrier D, Mayersohn M, Bressler R "Dose tolerance and pharmacokinetic studies of L (+) pseudoephedrine capsules in man." Eur J Clin Pharmacol 14 (1978): 253-9

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11. Keays R, Harrison PM, Wendon JA, et al "Intravenous acetylcysteine in paracetamol induced fulminant hepatic failure: a prospective controlled trial." BMJ 303 (1991): 1026-9

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22. Bonkovsky HL, Kane RE, Jones DP, Galinsky RE, Banner B "Acute hepatic and renal toxicity from low doses of acetaminophen in the absence of alcohol abuse or malnutrition - evidence for increased susceptibility to drug toxicity due to cardiopulmonary and renal insufficiency." Hepatology 19 (1994): 1141-8

23. Wong V, Daly M, Boon A, Heatley V "Paracetamol and acute biliary pain with cholestasis." Lancet 342 (1993): 869

24. Johnson GK, Tolman KG "Chronic liver disease and acetaminophen." Ann Intern Med 87 (1977): 302-4

25. Seeff LB, Cuccherini BA, Zimmerman HJ, Adler E, Benjamin SB "Acetaminophen hepatotoxicity in alcoholics." Ann Intern Med 104 (1986): 399-404

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36. Bougie DW, Benito AI, Sanchez-Abarca LI, Torres R, Birenbaum J, Aster RH "Acute thrombocytopenia caused by sensitivity to the glucuronide conjugate of acetaminophen." Blood 109 (2007): 3608-9

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38. Shelley WB, Shelley ED "Nonpigmenting fixed drug eruption as a distinctive reaction pattern: examples caused by sensitivity to pseudoephedrine hydrochloride and tetrahydrozoline." J Am Acad Dermatol 17 (1987): 403-7

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40. Kalyoncu AF "Acetaminophen hypersensitivity and other analgesics." Ann Allergy 72 (1994): 285

41. Tomb RR, Lepoittevin JP, Espinassouze F, Heid E, Foussereau J "Systemic contact dermatitis from pseudoephedrine." Contact Dermatitis 24 (1991): 86-8

42. Van Diem L, Grilliat JP "Anaphylactic shock induced by paracetamol." Eur J Clin Pharmacol 38 (1990): 389-90

43. Doan T "Acetaminophen hypersensitivity and other analgesics - response." Ann Allergy 72 (1994): 285

44. Camisa C "Fixed drug eruption due to pseudoephedrine." Cutis 41 (1988): 339-40

45. Leung R, Plomley R, Czarny D "Paracetamol anaphylaxis." Clin Exp Allergy 22 (1992): 831-3

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47. Thomas RH, Munro DD "Fixed drug eruption due to paracetamol." Br J Dermatol 115 (1986): 357-9

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